Exempt & Expedited Research

IRB: Human Subjects

IRB regulations provide a streamlined review process for research that falls into
categories specified as “Exempt” or “Expedited.” The streamlined review process means
that the research can be reviewed by one member of the IRB committee, which allows
approval to be granted more quickly.

Expedited Research

The IRB Chair (or the Chair’s designee) must confirm that research falls into one
of the exemption categories. Investigators may not make their own determination of
exemption. A determination that research is exempt does not absolve the investigators
from ensuring that the welfare of human subjects participating in research activities
is protected, and that methods used and information provided to gain subject consent
are appropriate to the activity. Investigators may not solicit subject participation
or begin data collection until they have received approval from the IRB to begin the
research. Categories of exempt research are described in section 46.101 of 45 CFR
46. Read 46.101 of 45 CFR 46 >>

Exempt Research

The IRB Chair (or the Chair’s designee) must confirm that research eligible for approval
using expedited procedures meets the same ethical standards as research requiring
full-board approval. Investigators may not solicit subject participation or begin
data collection until they have received approval from the IRB to begin the research.
Categories of research eligible for expedited review are listed by the Office for
Human Research Protections within the U.S. Department of Health and Human Services.
Read protections >>